Spinal implant system and method

ABSTRACT

A spinal implant includes an implant body extending between an anterior surface and a posterior surface. The implant body includes a first vertebral engaging surface and a second vertebral engaging surface. The implant body defines a cavity. A plate is connectable with the implant body via a coupling member adjacent the cavity and is translatable relative thereto. The coupling member has a portion including a frangible torque limit. The plate defines at least one opening oriented to implant a fastener with tissue. Systems, spinal constructs, surgical instruments and methods are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to aspinal implant system and a method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as degenerative disc disease, discherniation, spondylolisthesis, stenosis, osteoporosis, tumor, scoliosisand other curvature abnormalities, kyphosis and fracture may result fromfactors including trauma, disease and degenerative conditions caused byinjury and aging. Spinal disorders typically result in symptomsincluding deformity, pain, nerve damage, and partial or complete loss ofmobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, correction, discectomy, microdiscectomy,corpectomy, decompression, laminectomy, laminotomy, foraminotomy,facetectomy and implantable prosthetics. As part of these surgicaltreatments, spinal constructs, such as, for example, bone fasteners,spinal rods and interbody devices can be used to provide stability to atreated region. For example, during surgical treatment, surgicalinstruments can be used to deliver components of the spinal constructsto the surgical site for fixation with bone to immobilize a joint.Certain spinal surgery approaches utilize a direct lateral approach toaccess intervertebral spaces, however, these techniques present certainchallenges due to the location of musculature and neural structuresembedded therein. This disclosure describes an improvement over theseprior technologies.

SUMMARY

In one embodiment, a spinal implant is provided. The spinal implantincludes an implant body extending between an anterior surface and aposterior surface. The implant body includes a first vertebral engagingsurface and a second vertebral engaging surface. The implant bodydefines a cavity. A plate is connectable with the implant body via acoupling member adjacent the cavity and is translatable relativethereto. The coupling member has a portion including a frangible torquelimit. The plate defines at least one opening oriented to implant afastener with tissue. In some embodiments, systems, spinal constructs,surgical instruments and methods are provided.

In one embodiment, a spinal implant includes an implant body extendingbetween an anterior surface and a posterior surface. The implant bodyincludes a first vertebral engaging surface and a second vertebralengaging surface. A plate is connectable with the implant body via acoupling member and defines a single opening oriented to implant afastener with tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a side view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosure;

FIG. 3 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae;

FIG. 4 is a perspective view of the components and vertebrae shown inFIG. 3;

FIG. 5 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae;

FIG. 6 is a perspective view of the components and vertebrae shown inFIG. 5;

FIG. 7 is a perspective view of the components and vertebrae shown inFIG. 5;

FIG. 8 is a cross section view of the components and vertebrae shown inFIG. 5;

FIG. 9 is a perspective view of the components and vertebrae shown inFIG. 5;

FIG. 10 is a side view of the components and vertebrae shown in FIG. 5;

FIG. 11 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae; and

FIG. 12 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure disposed with vertebrae.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a spinal implant system and a method for treating a spine. In someembodiments, the systems and methods of the present disclosure areemployed with a spinal joint and fusion, for example, with a cervical,thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system includes an interbodyimplant. In some embodiments, the interbody implant includes aninterbody cage. In some embodiments, the surgical system includes aplate that is affixed to an interbody implant and a superior vertebralbody and/or an inferior vertebral body adjacent an interbody space ofvertebrae. In some embodiments, the surgical system includes aninterbody implant connected with a plate, locks and/or insertionmechanisms. In some embodiments, the surgical system includes one ormore radiographic markers selectively disposed with one or morecomponents of the surgical system. In some embodiments, the surgicalsystem includes a hyper-lordotic interbody implant configured to achievelordosis of vertebrae in a range of greater than 12 angular degrees.

In some embodiments, the surgical system includes instrumentation thatis employed with a method to anchor an interbody implant within aninterbody space of vertebrae. In some embodiments, the method includesthe step of disposing a hyper-lordotic interbody implant configured toachieve lordosis of vertebrae in a range of greater than 12 angulardegrees within an interbody space. In some embodiments, the presentsystem avoids migration of the interbody implant within the interbodyspace. In some embodiments, the interbody implant includes a plate thatis modularly or removably connected to the interbody implant via a setscrew. In some embodiments, the plate is attached to a lateral orantero-lateral aspect of a vertebra outside the interbody space using abone screw. In some embodiments, the surgical system includes a platethat is not attached with the interbody implant.

In some embodiments, the surgical system includes a plate that isconnected to an interbody implant and the plate includes a single bonescrew engageable with a vertebral body adjacent an interbody space ofvertebrae. In some embodiments, the single bone screw is configured toanchor the interbody implant and/or plate with tissue. In someembodiments, the single bone screw includes a buttress configuration. Insome embodiments, the interbody implant is not attached with the plate.

In some embodiments, the surgical system includes a plate that isconnected to an interbody implant and the plate includes a two bonescrew assembly engageable with vertebrae adjacent an interbody space ofthe vertebrae. In some embodiments, the two bone screw assembly isconfigured to anchor the interbody implant and/or plate with tissue. Insome embodiments, the two bone screw assembly is configured to providestabilization between vertebra. In some embodiments, the surgical systemincludes a plate that is connected to an interbody implant and the plateincludes a four bone screw assembly engageable with vertebrae adjacentan interbody space of the vertebrae. In some embodiments, the four bonescrew assembly is configured to anchor the interbody implant and/orplate with tissue. In some embodiments, the four bone screw assembly isconfigured to provide stabilization between vertebra.

In some embodiments, the surgical system includes a plate that isconnected to an interbody implant via a set screw. In some embodiments,the set screw includes a break off portion or head that is removable,separable or frangible at a selected torque limit. In some embodiments,the surgical system is employed with a method such that the interbodyimplant and plate assembly is positioned with an interbody space andbone screws attach the plate to tissue. In some embodiments, the methodincludes the step of breaking off the set screw head to release theassembly from a surgical inserter. In some embodiments, the surgicalinserter includes a screw driver.

In some embodiments, the surgical system is configured to resist and/orprevent migration of the interbody implant within an interbody space. Insome embodiments, the surgical system includes a plate that is modularlyor removably connected to the interbody implant by a set screw. In someembodiments, the plate is attached to a lateral or antero-lateralportion of vertebra outside the interbody space using a bone screw. Insome embodiments, the interbody implant is a standalone interbodyimplant.

In some embodiments, the surgical system includes a plate that isconnected to an interbody implant via a set screw, the plate includingone or more bone screws for fixation with tissue. In some embodiments,the plate includes an element to resist and/or prevent backout of thescrews from the interbody implant and plate assembly and/or tissue. Insome embodiments, the element includes a surface that is disposed withthe set screw and a bone screw to resist and/or prevent backout of theset screw and the bone screw. In some embodiments, the surface includesa cam lock capture member that is disposed with the set screw and a bonescrew to resist and/or prevent backout of the set screw and the bonescrew. In some embodiments, the surface is movable into alignment withthe set screw and a bone screw to resist and/or prevent backout of theset screw and the bone screw. In some embodiments, the surface isrotatable into alignment with the set screw and a bone screw.

In some embodiments, the surgical system includes an interbody implantand plate assembly having two bone screws. In some embodiments, theinterbody implant and plate assembly includes an element to resistand/or prevent backout of the two bone screws and the set screw from theinterbody implant and plate assembly and/or tissue. In some embodiments,the surgical system includes an interbody implant and plate assemblyhaving four bone screws. In some embodiments, the interbody implant andplate assembly includes an element to resist and/or prevent backout ofthe four bone screws and the set screw from the interbody implant andplate assembly and/or tissue.

In some embodiments, the surgical system is used with surgicalnavigation, such as, for example, fluoroscope or image guidance. In someembodiments, one or all of the components of the surgical system aredisposable, peel-pack, pre-packed sterile devices. One or all of thecomponents of the surgical system may be reusable. The surgical systemmay be configured as a kit with multiple sized and configuredcomponents.

In some embodiments, the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In someembodiments, the present disclosure may be employed with other ostealand bone related applications, including those associated withdiagnostics and therapeutics. In some embodiments, the disclosedsurgical system may be alternatively employed in a surgical treatmentwith a patient in a prone or supine position, and/or employ varioussurgical approaches to the spine, including anterior, posterior,posterior mid-line, direct lateral, postero-lateral, and/or anterolateral approaches, and in other body regions. The present disclosuremay also be alternatively employed with procedures for treating thelumbar, cervical, thoracic, sacral and pelvic regions of a spinalcolumn. The system and methods of the present disclosure may also beused on animals, bone models and other non-living substrates, such as,for example, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. As used in the specification andincluding the appended claims, the term “tissue” includes soft tissue,ligaments, tendons, cartilage and/or bone unless specifically referredto otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference is made in detail to the exemplary embodiments ofthe present disclosure, which are illustrated in the accompanyingfigures. Turning to FIG. 1, there are illustrated components of asurgical system, such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, commercially pure titanium, titanium alloys,Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys,superelastic metallic alloys (e.g., Nitinol, super elasto-plasticmetals, such as GUM METAL®), ceramics and composites thereof such ascalcium phosphate (e.g., SKELITE™), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate such as hydroxyapatite (HA),corraline HA, biphasic calcium phosphate, tricalcium phosphate, orfluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, orother resorbable polymers such as polyaetide, polyglycolide,polytyrosine carbonate, polycaroplaetohe and their combinations,biocompatible ceramics, mineralized collagen, bioactive glasses, porousmetals, bone particles, bone fibers, morselized bone chips, bonemorphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, orrhBMP-7, demineralized bone matrix (DBM), transforming growth factors(TGF, e.g., TGF-β), osteoblast cells, growth and differentiation factor(GDF), insulin-like growth factor 1, platelet-derived growth factor,fibroblast growth factor, or any combination thereof.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a fully opensurgical procedure, a minimally invasive procedure, includingpercutaneous techniques, and mini-open surgical techniques to deliverand introduce instrumentation and/or an implant, such as, for example,an interbody implant, at a surgical site of a patient, which includes,for example, a spine having vertebrae V, as shown in FIG. 3. In someembodiments, a surgical pathway P to a surgical site is formed via anoblique lateral interbody fusion (OLIF) or a direct lateral interbodyfusion (DLIF) procedure. In some embodiments, the implant can includespinal constructs, such as, for example, bone fasteners, spinal rods,connectors and/or plates.

Spinal implant system 10 includes an implant body, such as, for example,an interbody cage 12. Cage 12 extends between a posterior surface 14 andan anterior surface 16 and defines an axis L1. Posterior surface 14 isconfigured to face a posterior side of a subject body B and be disposedadjacent a posterior portion of vertebrae, such as, for example, aposterior portion P1 of one or more intervertebral spaces of vertebraeV, as shown in FIG. 4. Anterior surface 16 is configured to face ananterior side of subject body B and be disposed adjacent an anteriorportion of vertebrae, such as, for example an anterior portion A1 of oneor more intervertebral spaces of vertebrae V.

In some embodiments, cage 12 includes a convex distal end, such as, forexample, a bullet nose 18 to facilitate insertion by a surgeon. In someembodiments, cage 12 may include chamfers, such as, for example, cutouts 20 a, 20 b disposed on bullet nose 18 such that cage 12 may beplaced in an intervertebral space to avoid impinging on variousstructures in or adjacent vertebral tissue, such as, for example, aspinal foramina.

In some embodiments, cage 12 includes any number and configuration ofradiopaque markers (such as tantalum pins (not shown)) for visualizing aposition of cage 12 using fluoroscopy during insertion, manipulation andimplantation thereof. In some embodiments, the markers may be placedobliquely on bullet nose 18, in sidewalls of cage 12 adjacent surfaces14, 16 and/or in a proximal end of cage 12. In some embodiments, themarkers may be placed parallel, oblique to and/or perpendicular tosurfaces 14, 16 as required to properly visualize the position of cage12 relative to surgical pathway P and/or relative to an oblique axis O,as shown in FIG. 3, to facilitate placement of cage 12, as describedherein.

Cage 12 includes a vertebral engaging surface 22 and a vertebralengaging surface 24. Surface 22 may be substantially planar andconfigured to engage endplate tissue of a vertebral body, such as, forexample, an endplate E1 of a vertebral level V1, as shown in FIG. 4.Surface 24 may be substantially planar and configured to engage endplatetissue of a vertebral body, such as, for example, an endplate E2 of avertebral level V2. In some embodiments, surface 22 and/or surface 24may be rough, textured, porous, semi-porous, dimpled, knurled, toothed,grooved and/or polished to facilitate engagement with tissue.

In some embodiments, surface 22 and/or surface 24 may be partiallyconvex along axis L1 and/or at least partially convex in a directionsubstantially perpendicular to an axis L2 (i.e., from surface 16 tosurface 14). In some embodiments, surface 22 and/or surface 24 may beangled along axis L1 or angled perpendicular to axis L1 such thatanterior surface 16 is taller than posterior surface 14 such that cage12 may be capable of creating and/or augmenting lateral or lordoticcurvature in a spine when implanted. In some embodiments, surface 22 andsurface 24 are disposed at a relative angular orientation to include ahyper-lordotic configuration to correct lumbar lordosis in situationswhere a natural curve of a lumbar region of the back is accentuated. Insome embodiments, surface 22 and surface 24 are disposed at a relativeangular orientation in a range of greater than 12 degrees.

In some embodiments, vertebral tissue includes intervertebral tissue,endplate surfaces and/or cortical bone. In some embodiments, surface 22and/or surface 24 may be coated with materials suitable for facilitatingor encouraging bony ongrowth or fusion including but not limited totitanium and HA coatings. In some embodiments, a titanium coating isapplied to surface 22 and/or surface 24 in a porous layer using plasmaspray technology.

Cage 12 has a substantially rectangular configuration and includes aninner surface 26 and an outer surface 28. Surface 26 defines an opening30 configured to receive an agent, which may include bone graft (notshown) and/or other materials, as described herein, for employment in afixation or fusion treatment. In some embodiments, a plan geometry ofcage 12 may have various configurations, such as, for example, oval,round, cylindrical, oblong, triangular, rectangular, polygonal havingplanar or arcuate side portions, irregular, uniform, non-uniform,consistent, variable, horseshoe shape, U-shape or kidney bean shape.

Outer surface 28 includes an oblique surface 44 that defines a cavity,such as, for example, an elongated opening 45. Elongated opening 45defines a track 46. Oblique surface 44 is oriented with cage 12 and insubstantial alignment with surgical pathway P, as shown in FIGS. 3 and4. Track 46 is in open communication with surface 44 to define a trackpathway 48 that facilitates translation and/or rotation of a plateconnected with cage 12, as described herein. In some embodiments,pathway 48 is arcuate in shape. In some embodiments, track 46 includes avarying radius of curvature. Track 46 includes a limit, such as, forexample, a lateral axis limit 50 and a limit, such as, for example, anoblique axis limit 52. Limits 50, 52 provide a range of translationrelative to cage 12 along track 46 and/or pathway 48, as discussedherein.

Member 54 is slidably engageable with track 46 for translation relativeto cage 12 along track pathway 48. In some embodiments, member 54 ismovable along track pathway 48 for translation substantially along axisL2 and/or transverse to axis L1. In some embodiments, member 54 ismovable along track pathway 48 for rotation about axis L2 and/or axisL1. In some embodiments, track pathway 48 includes an arcuateconfiguration. In some embodiments, track pathway 48 extends along anarcuate configuration that is substantially concentric with track 46and/or a lateral surface of cage 12. In some embodiments, track 46,surface 44 and/or track pathway 48 may be arcuate with a single radiusdefining an arcuate configuration. In some embodiments, track 46,surface 44 and/or track pathway 48 may be arcuate with multiple radiidefining one or more portions of an arcuate configuration.

In some embodiments, track 46, surface 44 and/or track pathway 48 mayextend along a pathway having various configurations corresponding to anoverall shape of cage 12, such as, for example, round, cylindrical,oblong, triangular, rectangular, polygonal having planar or arcuate sideportions, irregular, uniform, non-uniform, consistent, variable,horseshoe shape, U-shape or kidney bean shape. In some embodiments, thesurfaces of cage 12 may be rough, textured, porous, semi-porous,dimpled, knurled, toothed, grooved and/or polished for selectivetranslation of member 54.

Spinal implant system 10 includes a plate 60, as shown in FIG. 2. Plate60 includes a surface 62 and a surface 64, as shown in FIG. 8. In someembodiments, plate 60 includes a substantially rectangularconfiguration. In some embodiments, plate 60 can be variouslyconfigured, such as, for example, tubular, oval, oblong, triangular,square, polygonal, irregular, uniform, non-uniform, variable, hollowand/or tapered. In some embodiments, plate 60 may be attached with cage12 prior to implantation, in vivo or in situ. In some embodiments, plate60 is removably connected with cage 12.

Plate 60 includes a surface 66 that defines an opening 68. Opening 68extends between surfaces 62, 64. Opening 68 is configured to receive acoupling member, such as, for example, a set screw 90, as describedherein. Opening 68 is configured for alignment with track pathway 48 andtrack 46 and facilitates engagement of set screw 90 with member 54, asdescribed herein. Plate 60 includes instrument engagement surfaces 70.Surfaces 70 are configured to engage a surgical instrument, such as, forexample, an inserter I to facilitate insertion and disposal of thecomponents of spinal implant system 10 at a surgical site, as describedherein.

Plate 60 includes a portion 72 configured to engage a vertebral level.Plate 60 includes a surface 74 that defines an opening 76. Opening 76extends between surfaces 62, 64. Opening 76 is configured to receive afastener 120, as described herein. Opening 76 orients fastener 120 forfixation with tissue, such as, for example, a vertebral level V1, asshown in FIG. 5. In some embodiments, a surgical instrument or tool, asdescribed herein, manipulates and/or rotates plate 60 about cage 12,opening 68 and/or tissue such that opening 76 is aligned with selectedvertebral tissue, for example, a superior vertebral body such asvertebral level V1 or an inferior vertebral body such as vertebral levelV2 for orienting a fastener for fixation of cage 12 and/or plate 60 withthe selected vertebral level. In some embodiments, a surgical instrumentor tool is engageable with portion 72, surface 74 and/or surface 66 torotate plate 60.

In some embodiments, plate 60 includes an element, such as, for example,a capture tab 78. In some embodiments, tab 78 is configured as arotating cam lock having a protrusion 102 and a protrusion 104.Protrusion 102 is configured to extend over and/or overlap all or aportion of fastener 120 to resist and/or prevent backout of fastener 120from plate 60 and/or tissue through opening 76, for example, which canbe caused by growth, movement and adjustments of vertebrae. Protrusion104 is configured to extend over and/or overlap all or a portion of setscrew 90 to resist and/or prevent backout of set screw 90 from plate 60and/or cage 12 through opening 68.

Tab 78 includes a portion 106 configured to facilitate movement ofprotrusions 102, 104 between a non-locking orientation, as shown in FIG.9, and a locking orientation, as shown in FIG. 10, relative to fastener120 and set screw 90. In some embodiments, portion 106 includes asurface that defines a cavity 108 having a hexagonal geometry configuredfor engagement with a similarly shaped surgical tool, such as, forexample, a portion of inserter I, as described herein. In someembodiments, cavity 108 includes a cruciform, phillips, square,hexalobe, polygonal or star cross sectional configuration for disposalof a correspondingly shaped portion of a surgical tool. In someembodiments, tab 78 is disposed within a cavity 110 of plate 60 forrotation relative thereto. In some embodiments, tab 78 is configured forrotation such that protrusions 102, 104 move into alignment withfastener 120 and/or set screw 90 to resist and/or prevent fastener 120and set screw 90 from disengaging from cage 12 and/or a vertebra.

In some embodiments, member 54 includes a spheroidal joint, such as, forexample, a ball screw 80 having an elongated post 82, as shown in FIG.8. Screw 80 is configured to provide freedom of movement and/or toggleof plate 60 relative to cage 12. Screw 80 is configured for engagementwith and translation along track 46 and/or track pathway 48. Post 82includes a surface 84 that defines a cavity 86. Surface 84 is configuredfor engagement with set screw 90 to fix plate 60 with cage 12. In someembodiments, set screw 90 is configured to draw plate 60 and cage 12together into an assembled orientation during insertion. In someembodiments, screw 80 provides translation of plate 60 relative to cage12 in a plurality of orientations in multiple planes.

In some embodiments, surface 44 and/or member 54 can comprise a dovetailor t-slot sliding attachment mechanism can be utilized for connectionplate 60 with cage 12. In some embodiments, plate 60 is freelytranslatable within the patient body such that plate 60 is configuredfor dynamic translation. In some embodiments, plate 60 is positionedwithin the patient body and locked into a fixed position with tissueand/or cage 12. In some embodiments, plate 60 is configured forselective positioning with a subject body for adapting to theconfiguration of the tissue surfaces of vertebrae, as well as providerange of motion limits 50, 52 for plate 60.

Screw 90 includes a portion 92 and a portion 94, as shown in FIG. 8.Portions 92, 94 are connected at a reduced diameter portion 96 that isfrangibly connected to portion 94. In some embodiments, portion 92 isconfigured for a threaded engagement with surface 84. In someembodiments, portions 92, 94 are fabricated from a fracturing and/orfrangible material such that manipulation of portion 94 relative toportion 92 can fracture and separate portion 94 from portion 92 at apredetermined force and/or torque limit, as described herein. In someembodiments, as force and/or torque is applied to portion 94 by inserterI and resistance increases, for example, due to fixation of portion 92with surface 84 of cavity 86, as described herein, the predeterminedtorque and force limit is approached. In some embodiments, portions 92,94 include offset hex geometries.

In some embodiments, portions 92, 94 can fracture and separate at apredetermined force or torque limit, which may be in a range ofapproximately 20 Newton centimeters (N-cm) to 50 N-cm. In someembodiments, portions 92, 94 may have the same or alternate crosssection configurations, may be fabricated from a homogenous material orheterogeneously fabricated from different materials, and/or alternatelyformed of a material having a greater degree, characteristic orattribute of plastic deformability, frangible property and/or break awayquality to facilitate fracture and separation of portions 92, 94.

Portion 92 includes a shaft 98 having an outer surface 100. Surface 100includes a thread form 102 configured for engagement with surface 84. Insome embodiments, thread form 102 is continuous along surface 100. Insome embodiments, thread form 102 may include a single thread turn or aplurality of discrete threads. In some embodiments, other penetratingelements may be located on shaft 98, such as, for example, a nailconfiguration, barbs, expanding elements, raised elements, ribs, and/orspikes to facilitate engagement of shaft 98.

In some embodiments, portion 94 includes an end having a hexagonalgeometry configured for engagement with a similarly shaped surgicaltool, such as, for example, a portion of inserter I, as describedherein. In some embodiments, end 94 includes a cruciform, phillips,square, hexalobe, polygonal or star cross sectional configuration fordisposal of a correspondingly shaped portion of a tool. Set screw 90 isconfigured to removably couple plate 60 with cage 12, as describedherein.

Spinal implant system 10 includes one or more fasteners 120 forattaching plate 60 and/or cage 12 to tissue, as described herein. Insome embodiments, fastener 120 may be engaged with tissue, such as, forexample, the bony structures of a vertebral body in variousorientations, such as, for example, series, parallel, offset, staggeredand/or alternate vertebral levels. In some embodiments, one or more offasteners 120 may comprise multi-axial screws, sagittal angulationscrews, pedicle screws, mono-axial screws, uni-planar screws, facetscrews, fixed screws, tissue penetrating screws, conventional screws,expanding screws, wedges, anchors, buttons, clips, snaps, frictionfittings, compressive fittings, expanding rivets, staples, nails,adhesives, posts, fixation plates and/or posts.

Fastener 120 comprises a portion, such as, for example, a head 122 and aportion, such as, for example, an elongated shaft 124 configured forpenetrating tissue. Head 122 includes an engagement portion configuredfor engagement with a surgical instrument, as described herein. Shaft124 has a cylindrical cross section configuration and includes an outersurface having an external thread form. In some embodiments, theexternal thread form may include a single thread turn or a plurality ofdiscrete threads. In some embodiments, other engaging structures may belocated on shaft 124, such as, for example, a nail configuration, barbs,expanding elements, raised elements and/or spikes to facilitateengagement of shaft 124 with tissue.

In some embodiments, all or only a portion of shaft 124 may havealternate cross section configurations, such as, for example, oval,oblong, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered. In someembodiments, the outer surface of shaft 124 may include one or aplurality of openings. In some embodiments, all or only a portion of theouter surface of shaft 124 may have alternate surface configurations,such as, for example, smooth and/or surface configurations to enhancefixation with tissue, such as, for example, rough, arcuate, undulating,porous, semi-porous, dimpled, polished and/or textured. In someembodiments, all or only a portion of shaft 124 may be cannulated.

In some embodiments, spinal implant system 10 may comprise varioussurgical instruments, such as, for example, drivers, extenders,reducers, spreaders, distracters, blades, forceps, elevators and drills,which may be alternately sized and dimensioned, and arranged as a kit.In some embodiments, spinal implant system 10 may comprise the use ofmicrosurgical and image guided technologies, such as, for example,surgical navigation components employing emitters and sensors, which maybe employed to track introduction and/or delivery of the components ofspinal implant system 10 and the surgical instruments described to asurgical site. See, for example, the surgical navigation components andtheir use as described in U.S. Pat. Nos. 6,021,343, 6,725,080,6,796,988, the entire contents of each of these references beingincorporated by reference herein.

In assembly, operation and use, as shown in FIGS. 3-10, spinal implantsystem 10, similar to the systems and methods described herein, isemployed with a surgical procedure for treatment of a spinal disorder,such as those described herein, affecting a section of a spine of apatient. The components of spinal implant system 10 are employed with asurgical procedure for treatment of a spinal disorder affecting asection of a spine of a patient, for example, to treat the affectedsection of vertebrae V of a patient utilizing an OLIF or OLIF procedure.

A retractor (not shown) is disposed in communication with surgicalpathway P for spacing tissue. In some embodiments, spinal implant system10 may include retractors such that no further probe is required. Insome embodiments, spinal implant system 10 may include retractorsconstrained via a frame or semi-constrained using an elastic or partialframe. In some embodiments, retractor blades are inserted simultaneouslyas part of a unitary retractor instrument around one or moreintervertebral spaces to protect vessels.

In some embodiments, an annulotomy and/or discectomy is performed with asurgical instrument with x-ray confirmation of the starting point thatis central on one or more intervertebral spaces. In some embodiments,spinal implant system 10 includes a semi-constrained retractor thatfacilitates minimal tissue pressures on surrounding abdominal structuresand provides flexibility such that its blades rotate on a fixed pinallowing greater degrees of freedom of movement and working angles for apractitioner.

A probe is passed into the disc space to secure its location. In someembodiments, the oblique angle and lordotic angle of the probe as itenters the disc space is assessed pre-operatively and measuredintra-operative using image guidance or using a mechanical or digitalprotractor. Fluoroscopy, image guidance and/or surgical navigation, asdescribed herein, is used to confirm proper probe alignment into thedisc space. In some embodiments, a guide wire is placed through acannula into the disc space and positioning is confirmed withfluoroscopy. Instruments, such as, for example, a Cobb, mallet, shaver,serrated curettes, rasp, a ring curette, a uterine curette and/or combotools are utilized to perform a discectomy of the disc space. Theinstruments enter the patient body obliquely through the retractor andcan be turned orthogonally to allow the surgeon to work orthogonallyacross the disc space. The disc space is distracted until adequate discspace height is obtained.

In some embodiments, a discectomy is performed via surgical pathway P.In some embodiments, trial implants are delivered along surgical pathwayP and used to distract one or more intervertebral spaces and applyappropriate tension in the intervertebral space allowing for indirectdecompression. In some embodiments, a direct decompression of the discspace is performed by removing a portion of a herniated disc. In someembodiments, the size of cage 12 is selected after trialing and cage 12is visualized by fluoroscopy and oriented before malleting into theintervertebral space. Trialing is utilized to establish a starting pointfor cage 12 insertion. In some embodiments, an anterior longitudinalligament (ALL) release procedure can be performed using an OLIF or aDLIF approach post-discectomy. For example, loosening the ALL can beperformed by placing holes or partial cuts in the ALL such that the OLIFsurgical pathway is immediately closer to the ALL.

A pilot hole(s) or the like is made in selected vertebra V1 of vertebraeV adjacent the intervertebral space, via surgical pathway P, forreceiving bone fastener 120. Inserter I is attached with cage 12 and/orplate 60, as described herein. Inserter I delivers cage 12 and plate 60along surgical pathway P adjacent to a surgical site for implantationadjacent the intervertebral space between vertebrae V1 and V2, as shownin FIGS. 3 and 4. In some embodiments, inserter I includes a navigationcomponent to facilitate placement of cage 12 and plate 60 betweenvertebrae V1, V2.

During insertion, inserter I is attached with plate 60 by arms 130, 132.Arms 130, 132 are configured to engage surfaces 70 to facilitatemanipulation of plate 60 relative to cage 12. Inserter I is connectedwith set screw 90 by a driver 134. Portion 94 of set screw 90 is engagedwith driver 134. Driver 134 and set screw 90 are utilized toprovisionally fix plate 60 and cage 12 with inserter I. Tightening ofset screw 90 causes cage 12, plate 60 and inserter I to be drawntogether and held in an assembled orientation during insertion.

Cage 12 and plate 60 are inserted through the retractor adjacent thesurgical site. Anterior surface 16 faces an anterior side of the patientbody adjacent anterior portion A1 and posterior surface 14 faces aposterior side of the patient body adjacent posterior portion P1, asdescribed herein. Surface 22 engages endplate tissue of endplate E1 andsurface 24 engages endplate tissue of endplate E2. In some embodiments,after implantation of cage 12 and plate 60, a practitioner can loosenthe connection of inserter I, cage 12 and plate 60. This configurationallows plate 60 to rotate and translate relative to cage 12, whichprovides cage 12 and plate 60 relative freedom of movement such that thepractitioner can maneuver the spinal construct for final placement ofcage 12 and/or plate 60.

Inserter I is an adaptable instrument configured to perform multipleapplications during a surgical procedure. In some embodiments, inserterI can prepare and/or create a cavity in tissue, such as, for example,bone. In some embodiments, inserter I guides a surgical instrument, suchas, for example, a drill, tap and/or an awl, as well as guidingfasteners to penetrate tissue. In some embodiments, inserter I is aguide that holds plate 60 and cage 12 together. Surgical instrumentsincluding an awl, a tap and screws can be passed through inserter I.

In some embodiments, inserter I is utilized to apply a force to plate 60such that plate 60 is translatable along track 46 and/or track pathway48, as shown by arrows C in FIG. 4. In some embodiments, plate 60 istranslated along track 46 to position plate 60 with vertebra V1. Plate60 is translated between lateral axis limit 50 and oblique axis limit 52to facilitate proper positioning of plate 60 relative to cage 12 andvertebra V1. Plate 60 is rotated into position such that portion 72 isoriented to engage vertebra V1, as shown in FIG. 5. Translation androtation of plate 60 allows selective manipulation of plate 60 tofacilitate plate 60 positioning relative to vertebra V1. In someembodiments, inserter I or other surgical instrument, as describedherein, engages portion 72 and/or surface 66 to rotate plate 60, in aclockwise or counter-clockwise direction, about opening 68 such thatopening 76 is selectively aligned with vertebral level V1 for orientingfastener 120 for fixation of cage 12 and/or plate 60 with vertebrallevel V1. In some embodiments, plate 60 can be rotated to align opening76 with a superior vertebral body such as vertebral level V1 or aninferior vertebral body such as vertebral level V2 for orientingfastener 120 to fix cage 12 and/or plate 60 with tissue.

Fastener 120 is aligned with opening 76 and tissue, and inserted alonginserter I via a driver 140. Fastener 120 is disposed with opening 76such that fastener 120 engages vertebra V1. Driver 140 is configured todrive, torque, insert or otherwise fasten fastener 120 with vertebra V1adjacent an intervertebral space S. In some embodiments, driver 140 mayinclude surgical navigation components, as described herein, toestablish a pathway for fastener 120 that is substantially concurrentwith and/or parallel to the surgical approach angle. In someembodiments, plate 60 is fixed with fastener 120 at an oblique anglerelative to cage 12. In some embodiments, plate 60 is fixed withfastener 120 laterally with cage 12.

Driver 134 is disposed with inserter I and rotated to fix plate 60 withcage 12, as shown in FIGS. 6-8. In some embodiments, plate 60 isconfigured for removable fixation with cage 12 such that plate 60 can beadjusted in situ and/or removed during a post-operative procedure.Driver 134 is rotated in a clockwise direction to manipulate set screw90 such that portion 94 separates from portion 92 at a predeterminedforce and/or torque limit, as described herein. Portion 94 is removedfrom inserter I.

Tab 78 is initially disposed in a non-locking orientation, as shown inFIG. 9. In some embodiments, driver 140 is engaged with tab 78, asdescribed herein, to actuate rotation of tab 78. Tab 78 is rotated intoa locking orientation, as shown in FIG. 10. In the locking orientation,protrusion 102 extends over and/or overlaps a portion of fastener 120 toresist and/or prevent backout of fastener 120 from plate 60 and/orvertebra V1 through opening 76 and protrusion 104 extends over and/oroverlaps a portion of set screw 90 to resist and/or prevent backout ofset screw 90 from plate 60 and/or cage 12 through opening 68.

Upon completion of a procedure, as described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incision(s) are closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiopaque markers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, the use of surgical navigation, microsurgical andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of spinal implant system10. In some embodiments, spinal implant system 10 may include one or aplurality of plates, connectors and/or bone fasteners for use with asingle vertebral level or a plurality of vertebral levels.

In some embodiments, spinal implant system 10 includes an agent, whichmay be disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the components and/orsurfaces of spinal implant system 10 with vertebrae. In someembodiments, the agent may include one or a plurality of therapeuticagents and/or pharmacological agents for release, including sustainedrelease, to treat, for example, pain, inflammation and degeneration.

In one embodiment, as shown in FIG. 11, spinal implant system 10,similar to the systems and methods described herein, includes cage 12,similar to that described herein and a plate 260, similar to plate 60described herein. Plate 260 includes a surface 262 and a surface 264.Plate 260 includes a surface 266 that defines an opening 268. Opening268 extends between surfaces 262, 264. Opening 268 is configured toreceive set screw 90 for connecting cage 12 and plate 260, similar tothat described herein. Opening 268 is configured for alignment withtrack 46 and facilitates engagement of set screw 90 with member 54, asdescribed herein. Plate 260 includes instrument engagement surfaces 270.Surfaces 270 are configured to engage an instrument, such as, forexample, an inserter I, as described herein.

Plate 260 includes a portion 272 configured to engage a vertebral levelV1 and a portion 280 configured to engage a vertebral level V2. Portion272 includes a surface 274 that defines an opening 276. Opening 276extends between surfaces 262, 264. Opening 276 is configured to receivea fastener 120, as described herein, and to align fastener 120 forfixation with vertebral level V1. Portion 280 includes a surface 284that defines an opening 286. Opening 286 extends between surfaces 262,264. Opening 286 is configured to receive a fastener 120, as describedherein, and to align fastener 120 for fixation with vertebral level V2.

In some embodiments, plate 260 includes a capture tab 278, similar totab 78 described herein. Tab 278 is configured as a rotating cam lockhaving a protrusion 482, a protrusion 484 and a protrusion 490.Protrusion 482 extends over and/or overlaps all or a portion of fastener120 to resist and/or prevent backout of fastener 120 from plate 260and/or vertebra V1 through opening 276. Protrusion 484 extends overand/or overlaps all or a portion of set screw 90 to resist and/orprevent backout of set screw 90 from plate 260 and/or cage 12 throughopening 268. Protrusion 490 extends over and/or overlaps all or aportion of fastener 120 to resist and/or prevent backout of fastener 120from plate 260 and/or vertebra V2 through opening 286. Tab 278 includesa portion 486, similar to portion 106 described herein, configured tofacilitate movement of protrusions 482, 484, 490 between a non-lockingorientation and a locking orientation relative to fasteners 120 and setscrew 90.

In one embodiment, as shown in FIG. 12, spinal implant system 10,similar to the systems and methods described herein, includes cage 12,similar to that described herein and a plate 360, similar to the platesdescribed herein. Plate 360 includes a surface 362 and a surface 364. Insome embodiments, plate 360 includes a substantially rectangularconfiguration. In some embodiments, plate 360 can be variouslyconfigured, such as, for example, tubular, oval, oblong, triangular,square, polygonal, irregular, uniform, non-uniform, variable, hollowand/or tapered. In some embodiments, plate 360 may be attached with cage12 prior to implantation or in situ. In some embodiments, plate 360 isremovably connected with cage 12.

Plate 360 includes a surface that defines an opening (not shown),similar to opening 68, which extends between surfaces 362, 364 and isconfigured to receive set screw 90 for connecting cage 12 and plate 360,similar to that described herein. Plate 360 includes instrumentengagement surfaces 370. Surfaces 370 are configured to engage aninstrument, such as, for example, an inserter I, as described herein.

Plate 360 includes a portion 372 configured to engage a vertebral levelV1 and a portion 380 configured to engage a vertebral level V2. Portion372 includes an opening 376 and an opening 390. Openings 376, 390 extendbetween surfaces 362, 364. Openings 376, 390 are configured to receivefasteners 120, as described herein, and to align fasteners 120 forfixation with vertebral level V1. Portion 380 includes an opening 386and an opening 392. Openings 386, 392 extend between surfaces 362, 364.Openings 386, 392 are configured to receive fasteners 120, as describedherein, and to align fasteners 120 for fixation with vertebral level V2.

In some embodiments, plate 360 includes a capture tab 378, similar tothe tabs described herein. Tab 378 is a rotating cam lock having aprotrusion 582, a protrusion 584, a protrusion 590 and a protrusion 592.Protrusions 582, 590 extend over and/or overlap all or a portion offasteners 120 to resist and/or prevent backout of fasteners 120 fromplate 360 and/or vertebra V1 through openings 376, 390. Protrusions 584,592 extend over and/or overlap all or a portion of fasteners 120 toresist and/or prevent backout of fasteners 120 from plate 360 and/orvertebra V2 through openings 386, 392. In some embodiments, tab 378 isconfigured to extend over and/or overlap all or a portion of set screw90 to resist and/or prevent backout of set screw 90 from plate 260and/or cage 12. Tab 378 includes a portion 586, similar to portion 106described herein, configured to facilitate movement of protrusions 582,584, 590, 592 between a non-locking orientation and a lockingorientation relative to fasteners 120 and set screw 90.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A spinal implant comprising: an implant bodyextending between an anterior surface and a posterior surface, andincluding a first vertebral engaging surface and a second vertebralengaging surface; a tab; and a plate connectable with the implant bodyvia a coupling member and defining a first opening oriented to implant afastener with tissue, a second opening configured for disposal of thecoupling member and a cavity having the tab positioned therein, the tabcomprising a body and an arm that extends from one side of the body, thetab being movable between a first orientation in which the arm overlapsthe openings and a second orientation in which the arm is spaced apartfrom the openings.
 2. A spinal implant as recited in claim 1, whereinthe plate is selectively fixable with and adjustable relative to anouter surface of the implant body.
 3. A spinal implant as recited inclaim 1, wherein the plate is rotatable relative to an outer surface ofthe implant body to align the opening with selected tissue.
 4. A spinalimplant as recited in claim 1, wherein the second opening is positionedbetween the first opening and the cavity.
 5. A spinal implant as recitedin claim 1, wherein the second opening is closer to the cavity than thefirst opening.
 6. A spinal implant as recited in claim 1, wherein thesecond opening has a maximum diameter that is less than a maximumdiameter of the first opening.
 7. A spinal implant as recited in claim1, wherein the arm includes a first portion that overlaps the firstopening when the tab is in the first orientation and a second portionthat overlaps the second opening when the tab is in the secondorientation, the first portion being continuous with the second portion.8. A spinal implant comprising: an implant body extending between ananterior surface and a posterior surface, and including a firstvertebral engaging surface and a second vertebral engaging surface, theimplant body defining a cavity; a member movably positioned within thecavity; a coupling member; a tab; and a plate connectable with themember via the coupling member, the coupling member having a body and aportion that is frangible from the body at a selected torque limit, theplate defining a first opening oriented to implant a fastener withtissue, a second opening having the coupling member positioned thereinand a cavity having the tab positioned therein, the tab comprising abody and an arm that extends from one side of the body of the tab, thetab being movable between a first orientation in which the arm overlapsthe openings and a second orientation in which the arm is spaced apartfrom the openings.
 9. A spinal implant as recited in claim 8, whereinthe plate is translatable along an arcuate path and an oblique surfaceof the implant body.
 10. A spinal implant as recited in claim 9, whereinthe oblique surface defines a range of movement of the plate between alateral axis and an oblique axis of the implant body.
 11. A spinalimplant as recited in claim 8, wherein the plate is selectively fixablewith and adjustable relative to an outer surface of the implant body.12. A spinal implant as recited in claim 8, wherein the vertebralengaging surfaces are disposed at a relative angular orientation in arange of greater than 12 degrees.
 13. A spinal implant as recited inclaim 8, wherein the coupling member includes a set screw having afrangible head.
 14. A spinal implant as recited in claim 8, the memberis movable relative to the plate and into alignment with the couplingmember and the fastener.
 15. A spinal implant as recited in claim 8,wherein the tab defines a backout element that is rotatable relative tothe plate and into alignment with the coupling member and a plurality offasteners.
 16. A spinal implant as recited in claim 8, wherein the tabdefines a rotatable cam that is movable into alignment with the couplingmember and the fastener.
 17. A spinal implant as recited in claim 8,wherein the plate is removably connected with the implant body.
 18. Aspinal implant as recited in claim 8, wherein the second opening ispositioned between the first opening and the cavity.
 19. A spinalimplant system comprising: a spinal implant including an implant bodyextending between an anterior surface and a posterior surface, andhaving a first vertebral engaging surface and a second vertebralengaging surface that are disposed at a relative angular orientation ina range of greater than 12 degrees, the implant body defining an arcuatecavity; a member movably positioned within the arcuate cavity; acoupling member; a tab; a plate connectable with the implant body viathe coupling member and being translatable relative thereto, thecoupling member having a body and a portion that is frangible from thebody at a selected torque limit, the plate defining a first openingoriented with tissue, a second opening having the coupling memberpositioned therein and a cavity having the tab positioned therein, thetab comprising a body and an arm that extends from one side of the bodyof the tab; a fastener disposable with the first opening; and a surgicalinstrument engageable with the coupling member to separate the portionfrom the body, wherein the tab is movable between a first orientation inwhich the arm overlaps the openings and a second orientation in whichthe arm is spaced apart from the openings.
 20. A spinal implant systemas recited in claim 19, wherein the surgical instrument is engageablewith the plate for selective fixation with and adjustment relative to anouter surface of the implant body.